OUTER SPACE: a randomised study on inhaler treatment adherence using a smart spacer in adults with asthma
- Conditions
- asthma
- Registration Number
- NL-OMON24135
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
(1) adults >= 18 years;
(2) physician diagnosed asthma treated in primary care;
(3) using any inhaled corticosteroid (ICS) (+/-long-acting beta agonist [LABA] +/- short-acting beta agonist [SABA]) administered by a pressurized Metered Dose Inhaler (pMDI) and a spacer;
(4) willing to sign informed consent.
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
(1) < 18 years;
(2) exacerbation in the last 3 months (defined as use of antibiotics and/or prednisone short-course and/or admission to a ED or hospital).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the overall feasibility of undertaking a definitive randomized controlled trial on the effects of tailored inhaler education by the GP/nurse supported by a smart spacer, in primary care treated adults with asthma
- Secondary Outcome Measures
Name Time Method 1) determine patient recruitment speed, participation rate (proportion of eligible patients), drop-out rate and inform sample size calculation for a definitive trial.<br>2) assess patient and healthcare provider satisfaction with the workflow (System Usability Scale [SUS]). <br>3) explore the distribution of medication adherence patterns (persistence and inhaler technique) and clinical outcomes (lung function, FeNO, Asthma Control Questionnaire [ACQ], Test for Adherence to Inhalers [TAI], and Work Productivity and Activity Impairment questionnaire [WPAI], SABA use, oral steroid bursts)<br>